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Aerotab Pain Reliever

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This product has been discontinued

Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 6, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 6, 2023
Manufacturer
Aero Healthcare
Registration number
part343
NDC root
55305-127
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

AEROTAB is an extra-strength pain reliever and fever reducer designed to help you feel better when you're experiencing minor aches and pains. Each packet contains 500 mg of acetaminophen (a common medication used to relieve pain and reduce fever) and 65 mg of caffeine, which can enhance the effectiveness of the pain relief.

This medication is effective for temporarily relieving discomfort from headaches and muscular aches, making it a helpful option when you need quick relief from these common issues.

Uses

You can use this medication to temporarily relieve minor aches and pains, such as headaches and muscular aches. It’s designed to help you feel more comfortable when you're experiencing these common discomforts.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

When taking this medication, it's important to follow the directions carefully. For adults and children aged 12 years and older, you should take 2 caplets by mouth every 6 hours. However, make sure not to exceed 8 caplets in a 24-hour period. If the person needing the medication is under 12 years old, you should consult a doctor for guidance on the appropriate dosage.

Remember, always take the caplets as directed and do not use more than the recommended amount. This will help ensure that you use the medication safely and effectively.

What to Avoid

You should avoid using this medication if you are allergic to acetaminophen, as it can cause serious reactions. Additionally, do not take it alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a drug contains acetaminophen, it's important to consult with your doctor or pharmacist for guidance. Taking these precautions will help ensure your safety and well-being.

Side Effects

You should be aware that acetaminophen can cause serious skin reactions, which may include symptoms like skin reddening, blisters, or rash. If you notice any of these signs, stop using the product immediately and seek medical help. Additionally, be cautious about liver health; taking more than 8 caplets in 24 hours, using other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage.

It's also important to note that the recommended dose contains about as much caffeine as a cup of coffee. Consuming too much caffeine can lead to nervousness, irritability, sleeplessness, and occasionally a rapid heartbeat. If you experience any new symptoms, notice redness or swelling in a painful area, or if your pain or fever worsens or lasts longer than the specified time frames, consult a doctor, as these could indicate a serious condition. Always talk to your doctor if you have liver disease or are taking blood thinners like warfarin before using this product.

Warnings and Precautions

You should be aware of some important warnings and precautions when using this product. First, if you notice any severe skin reactions such as reddening, blisters, or a rash, stop using the product immediately and seek medical help. Additionally, be cautious with the amount you take, as exceeding 8 caplets in 24 hours, combining it with other acetaminophen-containing medications, or consuming 3 or more alcoholic drinks daily can lead to severe liver damage. If you consume caffeine, remember that this product contains a similar amount to a cup of coffee, so limit other caffeine sources to avoid side effects like nervousness or rapid heartbeat.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you experience any new symptoms, notice redness or swelling in a painful area, or if your pain or fever worsens or lasts longer than the specified time frames, stop using the product and contact your doctor, as these could indicate a serious condition. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if no symptoms are present.

Overdose

Taking more than 8 caplets of this product in a 24-hour period can lead to severe liver damage. It's also important to be cautious if you are using other medications that contain acetaminophen, as combining them can increase the risk of liver harm. Additionally, consuming three or more alcoholic drinks daily while using this product can also result in serious liver damage.

If you suspect an overdose, look out for signs such as nausea, vomiting, loss of appetite, confusion, or jaundice (yellowing of the skin or eyes). If you experience any of these symptoms or believe you have taken too much, seek immediate medical help. It's always better to be safe and get checked by a healthcare professional.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours, but do not exceed 8 caplets in a 24-hour period.

In the event of an overdose, it is crucial to seek medical help immediately for both adults and children, even if there are no noticeable signs or symptoms. Always prioritize safety and follow these guidelines to ensure the well-being of your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken. Always prioritize safety and open communication with your healthcare team when managing health conditions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 8 caplets in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, avoid using other medications that also contain acetaminophen, as this can increase your risk of liver injury.

It's also crucial to limit alcohol consumption to fewer than 3 drinks per day while using this product, as drinking alcohol can further strain your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety when using medications.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this product, especially if you are taking the blood thinner warfarin, as it may affect how your medications work together. Additionally, be cautious with caffeine—try to limit your intake of caffeine-containing foods, drinks, or medications while using this product, as too much caffeine can lead to feelings of nervousness, irritability, sleeplessness, and even a rapid heartbeat.

You should also avoid using this product alongside any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, don't hesitate to ask your healthcare provider for guidance. Always prioritize open communication with your healthcare team to ensure your safety and well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This helps maintain its effectiveness. Always check the pouch before use; do not use the product if the pouch is torn or open, as this could compromise its safety and integrity.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is AEROTAB used for?

AEROTAB is a pain reliever and fever reducer that temporarily relieves minor aches and pains due to headaches and muscular aches.

What are the key ingredients in AEROTAB?

The key ingredients in AEROTAB are 500mg of acetaminophen and 65mg of caffeine.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 caplets every 6 hours, not exceeding 8 caplets in 24 hours.

What should I do if I am allergic to acetaminophen?

Do not use AEROTAB if you are allergic to acetaminophen or if you are taking any other drug containing acetaminophen.

What are the warnings associated with AEROTAB?

Warnings include the risk of severe skin reactions, liver damage from excessive use, and potential side effects from caffeine, such as nervousness and irritability.

What should I do in case of an overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Can I use AEROTAB if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using AEROTAB.

What should I do if new symptoms occur while using AEROTAB?

Stop use and ask a doctor if any new symptoms occur, if the painful area is red or swollen, or if pain or fever worsens or lasts longer than specified.

Packaging Info

Below are the non-prescription pack sizes of Aerotab Pain Reliever (pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aerotab Pain Reliever.
Details

Drug Information (PDF)

This file contains official product information for Aerotab Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

AEROTAB is an extra strength pain reliever and fever reducer formulated to provide effective relief from aches and pains. Each packet contains two tablets, with each tablet comprising 500 mg of acetaminophen and 65 mg of caffeine. The combination of these active ingredients is designed to enhance the analgesic effects of acetaminophen, making it suitable for the management of mild to moderate pain and the reduction of fever.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headaches and muscular aches.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication is intended for oral administration. Adults and children aged 12 years and older should take 2 caplets every 6 hours, with a maximum dosage of 8 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations. It is imperative that the medication is not used in excess of the directed dosage.

Contraindications

Use of this product is contraindicated in patients with a known allergy to acetaminophen. Additionally, it should not be used concurrently with any other medications that contain acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product contains acetaminophen, and there is a significant risk of severe liver damage if the following conditions are met: exceeding 8 caplets within a 24-hour period (the maximum daily amount), concomitant use with other medications containing acetaminophen, or the consumption of three or more alcoholic drinks daily while using this product.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should advise patients to limit the use of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients with liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

In the case of an overdose, immediate medical attention is crucial. Patients should contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, even if no signs or symptoms are apparent.

Patients are advised to discontinue use and consult a healthcare professional if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product.

Severe skin reactions have been reported, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

There is a significant risk of severe liver damage associated with the use of this product, particularly if patients exceed the maximum recommended dosage of 8 caplets in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product. Patients with pre-existing liver disease should consult a healthcare professional prior to use.

Caffeine-related adverse reactions may occur, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine intake can lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients are encouraged to limit the use of other caffeine-containing medications, foods, or beverages while taking this product.

Patients should stop use and consult a healthcare provider if any new symptoms arise, if the painful area becomes red or swollen, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts for more than 3 days, as these may indicate a serious condition.

Additionally, patients taking the blood-thinning medication warfarin should seek advice from a healthcare professional before using this product to avoid potential interactions.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication. The combination may necessitate careful monitoring due to potential interactions that could affect anticoagulation levels.

Caution is advised regarding the consumption of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. It is recommended to limit caffeine intake to mitigate these risks.

This product should not be used in conjunction with any other medications that contain acetaminophen, whether prescription or over-the-counter. Patients uncertain about the acetaminophen content in their medications should seek guidance from a healthcare professional to avoid the risk of overdose.

Packaging & NDC

Below are the non-prescription pack sizes of Aerotab Pain Reliever (pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aerotab Pain Reliever.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period.

In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, regardless of the presence of signs or symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Taking more than 8 caplets within a 24-hour period, which is the maximum recommended daily dosage, can lead to severe liver damage. Healthcare professionals should be vigilant in assessing patients who may have exceeded this limit.

Additionally, the concomitant use of this product with other medications containing acetaminophen poses a further risk of severe liver damage. It is crucial for healthcare providers to inquire about all medications a patient is taking to prevent potential interactions that could exacerbate liver toxicity.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk of severe liver damage. Healthcare professionals should advise patients on the dangers of alcohol consumption in conjunction with this medication.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should initiate appropriate management procedures, which may include monitoring liver function tests and providing supportive care as necessary. It is essential to educate patients on the importance of adhering to the recommended dosage and the potential risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 or seek medical help right away, as prompt attention is critical for both adults and children, even if no signs or symptoms are immediately apparent.

Storage and Handling

The product is supplied in pouches that must be stored at a temperature range of 20-25°C (68-77°F). It is imperative that the pouches remain intact; do not use if the pouch is torn or open. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Aerotab Pain Reliever, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Aerotab Pain Reliever, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.